Curative Chemoradiation of Low Rectal Cancer (WW2)

Vejle Hospital

Status: Active, not recruiting

Conditions: Rectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02438839

WW2

Details and patient eligibility

About

The aim of the present study is to investigate whether curative chemoradiation of low rectal cancer is feasible, safe and effective in a multicenter study with results comparable to those of single center studies.

Results from previous studies indicate that a considerable fraction of patients with low rectal cancer can be cured by a combination of radiation and chemotherapy alone and thus be spared from operation.

Enrollment: 105 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histopathologically verified adenocarcinoma of the rectum

• Planned abdominoperineal resection (APR) or ultralow resection

• Primary, resectable T1-T3, N0 tumor. N1 nodal disease is acceptable, if the positive lymph nodes are localized to the mesorectum at the level of the tumor.

• Distance from anal verge to lower edge of tumor ≤ 6 cm measured by rigid rectoscope

• Performance status 0-2

• Patient acceptance to collection of biopsies and blood samples for translational research

• Age ≥ 18 years

• Normal function of bone marrow as evaluated by

  • neutrophils ≥ 1.5 x 10^9/l
  • thrombocytes ≥ 100

• Normal function of liver

  • alanine aminotransferase (ALAT) < 2.5 x upper limit of normal
  • bilirubin < 2.5 x upper limit of normal

• Kidney function

  • Serum creatinine < 1.5 x upper limit of normal or measured glomerular filtration rate (GFR) > 30 ml/min

• Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.

• Written and orally informed consent

Exclusion criteria

• Previous surgical treatment of the present cancer, including transanal excision of tumor.
• Other malignant disease within the past five years except basocellular skin cancer and carcinoma in situ cervicis uteri
• Distant metastases verified by imaging or biopsy
• Previous radiation treatment of the pelvis
• Pregnant or breastfeeding women